In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
News|Articles|September 26, 2023
How to mitigate risk for biologics during fill/finish manufacturing
Author(s)Emergent
As more biologics move through research and development, the demand for specialized aseptic fill/finish services has steadily climbed. Aseptic processing with the highest degree of sterility assurance, filling accuracy and quality is critical for high-value, small-batch therapies. Anything less impacts regulatory compliance, project timelines and—most importantly—patient safety. This white paper explores the specialized equipment, expertise, and services needed for efficient biologics fill/finish manufacturing.
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